Skip to content

Disposable sample collector

by Guangzhou Richen-Frinse Optical &Electronic Co., Ltd. 2 variants

Ref HY-BB-13CModel HY-BB

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697242624DS01GR Basic UDI-DI 06972426240190UDI-DIDate12 Jan 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Disposable sample collector
Model / Reference
HY-BB, HY-BB-13C
Primary DI / UDI-DI
06972426240190
Basic UDI-DI
697242624DS01GR
Direct Marketing DI
06972426240190
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000029615
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Guangzhou Richen-Frinse Optical &Electronic Co., Ltd.

Properties

Other properties (11)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No